Operation and Maintenance of Ring Forming Tool

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the ring forming tool in the pharmaceutical manufacturing process.

2) Scope

This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the ring forming tool in the manufacturing facility.

3) Responsibilities

It is the responsibility of production operators, maintenance staff, and quality control personnel to follow this SOP to ensure proper operation and maintenance of the ring forming tool.

4) Procedure

4.1 Preparation

1. Verify the availability of raw materials, batch records, and specifications for ring formation.
2. Inspect the ring forming tool for cleanliness and ensure all components are in proper working order.
3. Ensure all safety protocols are followed, including wearing appropriate PPE.

4.2 Ring Forming Process

1. Set up the ring forming tool according to the specified size and shape requirements.
2. Feed the material into the forming tool and start the forming process.
3. Monitor the forming process to ensure consistency and quality of formed rings.

4.3 Cleaning and Maintenance

1. After completing the forming process, clean the tool thoroughly to remove any residues.
2. Inspect and lubricate moving parts as per the maintenance schedule.
3. Document cleaning and maintenance activities in the logbook.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Ring forming tool specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for ring forming tool

8) SOP Version

Version 1.0